Pharmacokinetics and Tolerability of 8.5g Oraqix^® in Patients with Generalized Periodontitis

Objectives: Oraqix®, a novel non-injectable anesthetic gel containing lidocaine and prilocaine and a thermosetting agent has been developed to provide localized anesthesia in periodontal pockets during scaling/root planing (SRP). The aim of this open study was to determine the plasma levels of lidocaine and prilocaine during following application of 8.5 g Oraqix® (5 cartridges). Methods: Eleven patients with generalized periodontitis (>49% of tooth pockets >5 mm and >23% of pockets >6 mm) participated in the study. Oraqix® was applied to the pockets during periodontal probing and SRP over a 2.6-3.4 h period. Blood samples were collected up to 10 h after the start of application of Oraqix®. Results: Peak plasma levels of lidocaine (0.16-0.55 mg/L) and prilocaine (0.05-0.18 mg/L) occurred 2.0-3.7 h and 2.0-3.3 h respectively after the start of application of Oraqix®. These levels are well below threshold levels for initial signs of CNS toxicity. Conclusion: Application of 8.5 g Oraqix® (212.5 mg of lidocaine base and 212.5 mg of prilocaine base) in periodontal pockets was well tolerated and displayed a wide safety margin with respect to systemic toxicity.